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Andrew C. von Eschenbach, M.D. - Press Tele-briefing

This text contains Dr. von Eschenbach's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.
Press Tele-briefingUnapproved Old Drugs w/ Carbinoxamine

Thank you all for joining us this morning. The efforts of the media in helping us spread the word of this action to consumers and health-care professionals are essential.

FDA is making two major announcements today that are a part of our continuing efforts to protect patients, people, and the public health, as well as to empower consumers with better knowledge — and also support Secretary Leavitt’s Department of Health and Human Services strategic goal of reducing major threats to the health and well-being of Americans.

There are drugs being sold to patients and advertised to doctors that have been around for a very long time and were never approved by FDA. In other words, they have never been submitted to the rigorous scientific evaluation for safety, efficacy, and manufacturing quality.

FDA has been focusing on this problem as one part of our drug safety initiative – announced last year – to ensure that patients, consumers, and health-care providers have the most up-to-date drug safety information. In focusing our attention on these old unapproved drugs, we have identified a drug we must take action on.

FDA is announcing its intention to take enforcement action to stop the manufacture and the sale of any unapproved products containing the antihistamine, carbinoxamine.

We are taking this action against these specific drugs because of mounting safety concerns regarding the use of these products in CHILDREN under the age of 2 years, and because some of these products are actually being marketed as infant drops.

FDA is dedicated and determined to meet our drug safety mission and to ensure that ALL drugs marketed in the United States meet safety, effectiveness, manufacturing, and labeling standards.

Today we are also announcing publication and availability of a final guidance document outlining FDA’s approach to addressing other medicines that are marketed without FDA approval.

Many of the unapproved drugs affected by today’s final guidance – including products such as those we are discussing today that contain the antihistamine, carbinoximine – are products that were developed and marketed before modern standards for drug approval were established.

As a physician, I welcome the opportunity to address what could be a significant public health issue related to drugs that have not been subject to FDA’s rigorous scientific review being provided to patients. Because these products have been on the market for a very long time, many of them are used in pharmaceutical and medical reference material, giving the false impression that they were reviewed and approved for safety and efficacy by the FDA. Because many of these drugs have been around for a long time there is a presumption that they are fine.

We hope our actions today will encourage the manufacturers of unapproved drugs to take independent action to provide the evidence and data that support that belief, and ensure that their products are of high quality, safe, and effective by complying with the drug approval process.

FDA is committed to making sure that patients are able to purchase drugs for themselves and their children and infants not on the “hope” that they are safe and effective, but with FDA-reviewed evidence and labeling that defines the conditions of their safety and effectiveness.

FDA approval of prescription and over-the-counter drugs is more than just a one-time stamp of approval. It is a framework for on-going oversight to ensure safety and efficacy through post-market monitoring, and annual updates to label information that help physicians and their patients make the most informed decisions about use based on the most current understanding of product risks and benefits.

In order to rationally and reasonably address this problem, the final Compliance Policy Guide issued by the FDA today outlines a risk-based enforcement approach that is flexible, but firm and includes:

Identification of illegally marketed drugs

Prioritization of those drugs based on their potential to harm the public health

Subsequent regulatory follow-up.
Working together with the companies and the stakeholders who depend on their drugs, we are committed to achieving this goal without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting patient access to drugs that MAY provide important health benefits.